Information about Military and Civilian Biodefense/Terrorism Countermeasures, vaccines, laws and policies

October 28, 2004

Federal Court Orders Pentagon to Stop Anthrax Immunization Program

Global Security Newswire

For a second time, a federal judge has ruled that the U.S. Defense Department must stop administering the anthrax vaccine to military personnel, concluding that the Food and Drug Administration did not meet the required review standards before allowing use of the vaccine, the Washington Post reported (see GSN, Sept. 9).

The Defense Department’s mandatory vaccination program, under which more than 1.2 million troops have been inoculated since 1998, must stop until the FDA reviews the anthrax vaccine properly for safety and effectiveness, according to a ruling yesterday by U.S. District Judge Emmet Sullivan.

Sullivan was particularly critical of the FDA for forgoing public comment before the agency first approved the vaccine last year, the Post reported.

“The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all — public scrutiny. This is the process the FDA in its expert judgment has outlined, and this is the course this court shall compel FDA to follow,” Sullivan wrote.

U.S. President George W. Bush, however, retains the power to waive the standard review process if he determines emergency circumstances exist, according to the ruling.

Sullivan initially ruled late last year, according to the Post, that the FDA had never approved the vaccine and ordered the inoculation program stopped. The FDA, however, approved the vaccine eight days later based on an application made 18 years earlier, and the program continued.

“As a result of the injunction, the Department of Defense will pause giving anthrax vaccinations until the legal situation is clarified,” the department said in a press release. “[The department] remains convinced that the anthrax immunization program complies with all the legal requirements and that the anthrax vaccine is safe and effective.” (Marc Kaufman, Washington Post, Oct. 28).

October 25, 2004

Companies On the Fence About Biodefense

The Scientist

Signed into law by President George W. Bush in July, Project BioShield allows the federal government to spend $5.6 billion over 10 years to purchase vaccines and drugs for smallpox, anthrax, botulinum toxin, Ebola virus, plague, and other pathogens and infections. While biotechnology and pharmaceutical companies praised the initiative at the time, most are still sitting on the sidelines, waiting for additional legislation that would make biodefense a more attractive business prospect.

Part of the reason is fear of litigation and huge damage awards. "Large pharmaceutical companies have so far not been interested in BioShield because of fear of being sued" if they make a vaccine or drug that has adverse health effects, says Frank Rapoport, managing partner at McKenna Long & Aldridge in Devon, Pa., which represents drug companies seeking government contracts.

Unlike traditional defense spending by the Pentagon, BioShield neither funds basic research nor mitigates the risk companies take in developing products for which no commercial markets exist, should the government not buy their offerings. "That's a very challenging thing to ask industry to do," says a Senate staffer familiar with BioShield who requested anonymity. "Privately, the companies are telling us that BioShield's provisions are not remotely enough."

Before jumping into the biodefense fray, industry executives would like to see a range of incentives including guarantees of procurement, R&D tax credits, and protection from liability. "It's clear that follow-up legislation is needed, specifically for liability and procurement issues," says Kim Coghill, spokesperson for the Biotechnology Industry Organization, a trade group in Washington, DC. "BioShield should not just authorize but guarantee that the government will purchase acceptable countermeasures."

DAFB civilians face 'backdoor draft'

Deleware Online

Many of the 1,000 key workers may quit over forced vaccinations.

A Department of Defense plan to increase the number of civilian personnel who receive the anthrax vaccine could lead to a mass exodus among the more than 1,000 skilled employees at Dover Air Force Base, union officials say.

A labor law expert says the requirement to take the anthrax vaccine may violate the workers' constitutional rights.

And a civilian engineering and airfield maintenance team based at Dover, which just received orders to take the controversial shots, is already balking at the requirement.

Nationwide, the defense department's 800,000 civilian employees are being drawn into the controversy over the anthrax vaccination program simmering among Air Force pilots and crews at Dover and around the country. The civilians, many former military, work as accounting technicians, aircraft mechanics, air traffic controllers and civil engineers, in addition to holding positions in the food service, supply, maintenance and medical fields.

A recent Pentagon initiative intended to make the military more mobile also affects civilian military workers: They must be ready to be deployed with troops in war zones around the world. That could include requiring vaccinations to protect them from biological attacks.

All U.S. troops deployed overseas must take a series of six anthrax vaccinations. Many around the world have refused and face possible court martial. Civilians employed by the military can be fired for failure to comply with military orders.

The News Journal reported earlier this month that the troops received anthrax vaccine starting in 1999 that may have contained squalene, a substance that can be used to increase the potency of vaccine. Some researchers believe that even trace amounts of squalene can suppress the immune system, causing arthritis, neurological problems, memory loss and incapacitating migraine headaches.

"It's conceivable that the entire Department of Defense civilian work force is at risk of the anthrax vaccine," said Brent Reynolds, president of the American Federation of Government Employees Local 1709 Inc., the union representing Dover's civilians. Reynolds is a jet aircraft mechanic at the base.

"In the 1960s, they wouldn't draft anyone over 35. Now they want to make guys in their 50s and 60s deployable," said Peter Buono, Local 1709's executive vice president and a machinist at the base.

The union's fight against the vaccination program so far has been unsuccessful.

Charges Reynolds and Buono filed with the Federal Labor Relations Authority were dismissed. They've tried without success to take their concerns to Air Force Col. John Pray, the base commander.

"He's the CEO of the base, but he won't meet with us," Reynolds said. "We can't even get him to the table to negotiate the shots."

Pray did not respond to numerous calls or e-mails seeking comment about the union leaders' concerns.

Pentagon spokesman James Turner said in a written statement that anthrax vaccinations are required for all Defense Department civilian workers designated as "emergency essential" and deployed or stationed in higher threat areas such the Middle East or Korea.

"The number of designated emergency essential civilians is a very small portion [generally less than 30,000] of the overall number of DoD personnel currently required to receive anthrax vaccinations in the higher threat areas," Turner wrote.

Dover's union leaders don't buy it. Their national union joined 39 others last month in a letter to every U.S. senator calling on the lawmakers to stop the forced vaccinations.

"It's nothing more than a back-door draft," Reynolds said. "If we're deployable, that makes us civilians in uniform. Are they going to issue us uniforms too? Are they going to hand us a gun? From now on, once we're all deployable, they're going to expedite the anthrax vaccination program. Many of our members are older. If they're required to take the shots, there's going to be a mass exodus."

Officials at Dover would not discuss potential losses in their civilian work force.

Neither Reynolds nor Buono could estimate the cost to replace union workers at the base.

"It would be in the millions," Buono said.

When pilots in 1999 were forced to take the vaccine, 55 pilots out of 120 in the Air Force Reserve wing stationed at Dover resigned, leaving the base below strength. The military has never released the cost of replacing them.

Many are older workers

Union officials say the 2004 Defense Authorization Act, known as the National Security Personnel System, is nothing more than an attempt to curb the unions' power and militarize their members.

According to Defense Department documents, the military hopes to create a more agile and responsive work force, where "employees and/or a work unit can be easily geographically moved either temporarily or permanently, to meet changing mission requirements. ..."

Most civilian defense employees are in their late 40s and 50s and sometimes 60s, much older than their military counterparts, union officials said. Many already have medical problems and do not want the added risks associated with the anthrax vaccine, which some researchers believe cause severe autoimmune disorders.

At the Pentagon, Turner repeated that the vaccine is safe, even for older civilian workers.

Reynolds and Buono said their members are afraid to come forward because they are supervised by military personnel and fear reprisals.

"These guys know they'll be disciplined in some way if they talk, on evaluations or bonuses, or by withholding their promotions," Reynolds said.

The union leaders predict chaos will result if their members resign en masse.

"Without us, they wouldn't be able to exist. They need our experience," Reynolds said. "You just can't walk in here and start working on a [C-5] aircraft that's two football fields long. You need experience."

The union wants the vaccination program to be voluntary.

"I'd prefer to take my chances with the disease," Buono said.

Problems emerged at Dover in May 1999 after some troops in their 20s and 30s began developing illnesses normally associated with old age.

Retired Col. Felix Grieder, who commanded Dover Air Force Base at the time, has concluded that his troops were the subjects of illegal experiments at the base. Grieder halted the vaccination program in 1999, a move he has said brought an end to his military career.

Military and international law prohibits giving troops drugs without their knowledge and consent. Federal law prohibits administering drugs that have not been approved by the Food and Drug Administration.

Neither the military nor the FDA test for squalene, a substance that occurs naturally in the body. Some experts say even trace amounts of squalene can suppress the immune system when the substance is injected into the body.

Testing by the FDA in 2000 detected squalene in varying amounts in the vaccine. The substance was detected in all the vaccine sent to Dover in 1999, but not in vaccine sent to other military installations.

The Air Force and the Department of Defense have continually stressed the safety of the vaccine, despite the claims of military personnel who say it made them ill.

The military has secretly experimented with squalene to test its ability to boost the effectiveness of some vaccines. The Department of Defense has admitted conducting tests on humans using squalene in vaccines in Thailand. But the military said any contamination in the vaccine in Dover must have occurred accidentally.

The military has said it suspects that the FDA conducted faulty tests and that the vaccine contained no squalene. It also contends that the amounts of squalene the FDA said were contained in the vaccine would have been too small to affect human health.

For the union, the vaccine has become an issue of top concern.

"The anthrax shots is the single biggest concern on this base in the past 20 years," Reynolds said.

Previous protests

Controversial immunizations and a reliance on civilian labor are nothing new to the U.S. military.

George Washington, while commander-in-chief of the Continental Army, caused an uproar by requiring militia men to submit to small pox vaccinations before they were allowed to fight.

"Washington created quite the row back then, getting all those Minutemen to come in, stand in line and get the small pox shot," said retired Army Maj. Gen. Dr. William Duncan. "In those days they actually gave the soldiers a dose of the small pox germ."

Duncan, a medical doctor and military historian, said the military's reliance on civilian labor has been increasing over time, because civilians provide a highly trained, but more importantly, stable work force.

"Military personnel generally rotate to new assignments every two or three years," he said. "There has always been a need for the civilians' stability at the camps and bases around the country. The technical experience needed to maintain a C-5 is phenomenal. You'll find the vast majority of people maintaining C-5s and helicopters are civilians, because they'll be there today, tomorrow and next week."

Legal precedent

Attorneys who specialize in labor and employment law say the mandatory nature of the anthrax vaccination program raises concerns for the civilian defense workers.

"The military operates with the attitude that they're totally unaccountable under the law," said Wilmington attorney Thomas Neuberger. "My point is, I have engaged in heavy-duty litigation with the Pentagon, and they think they can do anything."

By requiring the vaccine, the Pentagon may be violating the constitutional rights of the civilian work force, in addition to federal labor laws, Neuberger said.

"Civilians have rights - entitlements to life, liberty and the pursuit of happiness - and happiness could very well mean your job," he said. "The military is not above the law. They will be handled by Congress, who will take them to their knees."

Local attorney Herb Feuerhake is troubled by what he sees as the Orwellian nature of the mandatory vaccinations.

"It comes down to the motivation of the Department of Defense. Presumably, these civilians could be sent to a remote location fraught with the potential for disease. It sounds like the clause in the contract covering vaccinations may have been insisted upon by the union to protect the workers," he said. "But here, it is being twisted around to force people to do something they do not want to do. That's what's odd. Something that was supposed to protect the worker is now feared."

The military would not comment on the legal issues posed by the civilian program.

Union leaders say they will continue to fight against the mandatory vaccinations.

"I'm trying to represent my members and protect their lives," Reynolds said. "I've got 1,000 lives to be concerned about."

Fear as money: How one company, skirting regulations, turns fear of anthrax into gold

MAKER OF ANTHRAX VACCINE VIOLATED REGULATIONS, EXPERTS BELIEVELATEST: FDA PRESS OFFICE: SITE PROMOTING VACCINE PAID FOR BY COMPANY NOT NECESSARILY CONSIDERED PROMOTIONBy John Byrne, RAW STORY Editor

Quietly lurking in the shadows of all three presidential debates has been the specter of terrorism. And as the fear of terrorism followed one debate to the next, so too did BioPort, the U.S. military’s sole provider of the anthrax vaccine.

Marred by the reports from hundreds of servicemembers who say they’ve been made ill by the vaccine since it was mandated 1998, three federal lawsuits about the vaccine’s safety and financial woes related to the government’s refusal to add the vaccine to its civilian defense stockpile, the has company launched an aggressive grass-roots marketing push.

To ensure that it nets the lucrative civilian contract, BioPort has systematically sought to elevate concern about the risk of anthrax exposure, successfully playing on local fears and paying “experts” thousands of dollars to produce reports that assert the threat of anthrax is immediate and grave.

It has also retained a medical professor to run a lobbying group while masking its own affiliation. The group has disseminated misleading information about adverse reactions to the vaccine, putting BioPort in apparent violation of federal regulations, RAW STORY has learned.

BioPort did not return repeated calls seeking comment. In the past, they have steadfastly defended their vaccine, which is their only financially significant product.

A press officer for the Food and Drug Administration said Monday that if BioPort paid a third-party to promote their vaccine, it might not be considered promotion, in apparent contradiction with the agency’s own federal regulations and industry experts. She said she would contact a relevant member of the FDA and provide further comment later today.

BioPort is battling a nascent rival company, VaxGen, to net the civilian contract. How the corporate war pans out could determine who will supply up to 75 million anthrax vaccine units – and whether troops continue be injected by a vaccine with a questionable safety record. VaxGen promises a cheaper and more effective next generation vaccine which has yet to win FDA approval.

But BioPort, saying they rely solely on their defense contract for research and development, state they don’t have the means to produce a new vaccine.

Yet the company has raised the price of the vaccine to the Defense Department by nearly a factor of ten; their original contract said the vaccine would be priced at under $3 per dose after 3.3 million doses. According to a 2001 company interview, the Pentagon now pays $22 per dose.

Their predicted price to the public?

“Somewhere in the neighborhood of between $70 to $100 per dose,” the company’s owner recently told a reporter.

COMPANY LOBBY LIKELY IN VIOLATION OF FEDERAL REGULATIONS

Like many companies, BioPort maintains a seemingly independent lobbying group. But unlike, say, the Recording Industry of America, whose financial backers are listed on their website, BioPort and their public relations firm have taken pains to mask their affiliation with the group.

Neither Bioport or their PR firm, Ruder Finn, are listed anywhere on the website of the group, the Partnership for Anthrax Vaccination Education.

The only member listed is George Washington University School of Public Health professor Muhiuddin Haider.

Haider, according to a listing of externally sponsored projects on the George Washington University website, is paid by BioPort. The “affiliated organization” is listed as Ruder Finn.

The site, which mentions the BioPort vaccine by name, provides misleading information about adverse effects of the vaccine, putting the company in likely violation of federal regulations.

Under a section titled “Myth vs. Fact about the Anthrax Vaccine,” the group asserts that it is a myth that the vaccine “has dangerous side effects including death.”

“Anthrax vaccine has never been determined by medical experts to have been the cause of any death,” the section states.

This contradicts facts presented by the Defense Department, which is a strong advocate of the vaccine.

Two 2003 military studies found that the vaccine was the probable cause of a reservist’s death. While Pentagon-paid physicians found the evidence was not conclusive because Specialist Rachel Lacy, 22, had also received other vaccines simultaneously, both panels asserted the vaccine was the probable cause of her death.

Additionally, the BioPort lobby fails to document any of the serious adverse reactions to the vaccine as mandated by federal regulations. According to the manufacturer’s own product package insert (view pdf file), the most common side effects reported to the government’s vaccine adverse effects reporting system were an allergic reaction in the skin, headaches, systemic joint pain and fatigue.

Not a single one of these effects are listed on the site.

Moreover, the insert also reports rare severe reactions to the vaccine, including systemic disorders in the nervous system, skin, musculoskeletal system, connective tissue, and bones.

None of these are listed or alluded to on the site, either.

BioPort’s insert, which increased to six pages from two in 2002 to document additional adverse effects, also notes that the Pentagon’s own survey studies found systemic adverse reactions in five to 35 percent of those vaccinated.

This, too, is not mentioned on the lobby’s site.

Under Part 202 of the Food and Drug Administration’s federal regulations, pharmaceutical companies are required to disclose the “true statement of information relating to side effects, contraindications, and effectiveness,” including “each specific side effect and contraindication.”

Wayne Pilot, a former assistant commissioner at the FDA and former employee of the Pharmaceutical Manufacturer’s Association, who now practices law specializing in FDA regulation, confirmed that BioPort was responsible for regulatory infractions of its lobbies.

“The party which has the licenses is responsible for any claims that are made about the product including those which are made by third parties,” Pilot said Monday. “The licensee is responsible for correcting those statements that may be incorrect or misleading.”

Sarah Barak, the editor of the FDA Advertising and Promotion Manual, an independently-published industry guide, agrees.

“If you have information on a website that’s tantamount to promotion than you need to follow the rules of that area of promotion,” Barak said.

Pilot also asserted that BioPort is required to report any supportable claims made by the Defense Department about adverse effects.

“If the information is supportable,” he added, “that’s the company’s responsibility.”

Pilot also stressed that violating the regulations was not a minor infraction.

“Those regulations have the force and effect of law,” he said.

The BioPort lobby also states that it is a myth that miscarriages are linked to the vaccine. What it does not note is that a 2002 Navy study found that use of the anthrax vaccine in pregnant women may cause a higher incidence of birth defects.

The preliminary study, which was supposed to be disclosed in April 2002, was never released.

Out of nearly a hundred projects listed as externally sponsored at the university for 2004, Haider’s is the only affiliated with a public relations firm. Most are affiliated with foreign governments or specific medical centers.

SOWING FEAR AT THE DEBATES, FOR PROFIT

When the final presidential debate got under way in Tempe, Arizona, the firm sponsored a roundtable in Phoenix on terrorism preparation.

In a release for the event, BioPort noted “growing border security concerns with Mexico” and that Timothy McVeigh “concocted their deadly truck bomb in nearby Bullhead City, Arizona.”

“Many of the country’s terrorist-like patriot militia groups operate throughout the Southwest desert area,” the release added. “And even the relatively peaceful Scottsdale area was the scene of a July bombing at a local eatery.”

Arizona’s roundtable was only the most recent of the company’s panels. In fact, the company sponsored local roundtables at all three presidential debates, the vice presidential debate and at both parties’ national conventions.

While RAW STORY does not have independent knowledge of what transpired at these events, there is no indication from their press releases that they made any public mention of adverse effects.

Barak, who authored the FDA industry manual, said BioPort was obligated the report adverse effects if they were marketing the vaccine.

“If you have benefit claims then you must present the risk,” she said.

The Miami roundtable, BioPort stated in their release, ended on a “high note” when a county commissioner offered to propose legislation which would set aside a $5 million fund, under which “BioPort would hold and earn interest on the money given by the state” with the condition that vaccines would be “delivered immediately in the case of an outbreak or threat of [an] anthrax scare.”

In their announcement of a roundtable for the Republican convention, BioPort claimed that a biological terrorist attack on the U.S. before the election was high, citing unnamed ‘security analysts.’

In 2002, the company paid six bioterrorism “experts” $55,000 to produce a report which said the United States could experience other occurrences such as the 2001 anthrax mailings. The company’s president noted that Iraq, Iran, Libya and North Korea have weaponized anthrax or are working to obtain it.

This approach has paid dividends.

In June, BioPort successfully lobbied the U.S. Conference of Mayors – in a possible infraction of FDA regulations the requires a company to disclose all side effects in their lobbying efforts – to endorse a resolution supporting the inclusion of BioPort’s vaccine to the civilian defense stockpile.

Yet after years of pressure and an anthrax attack on Congress, the Department Health and Human Services has declined to add the vaccine to the stockpile. While they have not explicitly stated the reason is linked to the safety of the vaccine, many see the decision to be a tacit rebuke to BioPort.

October 21, 2004

Louisville Guardsman Says Anthrax Shot Made Him Ill

Alabama Congressman Trying To Help ManWLKY News

A Louisville man ready to fight for his country is now fighting to regain his health.Aaron Haycraft, 23, an Air National Guard member, is in the Mobile, Ala., area, WLKY NewsChannel 32 reported. He's getting treatment from a doctor at the nearby Air Force base there. Haycraft said his health problems began in May 2003, after receiving an ordered anthrax shot before being deployed to Iraq, WLKY reported. Now, he shakes constantly and needs help moving around his apartment. He said the Air Force won't give him a medical discharge.

The Air Force has sent Haycraft paperwork that orders him to return to duty, even though he says he's not physically ready.

A congressman from Alabama is trying to help him, but said the Air Force has not returned his phone calls yet, WLKY reported.

Please follow WLKY NewsChannel 32 and TheLouisvilleChannel.com for updates to this story as they become available.

Pentagon says 200,000 who started anthrax-shot regimen must continue

By Sandra Jontz, Stars and Stripes

ARLINGTON, Va. — Troops who received some of their anthrax inoculations before the Pentagon halted it 3 years ago have until Dec. 31 to resume their six-shot regimen, no matter where they might be stationed, officials said.

About 200,000 troops need to pick up the vaccination where they left off, even if it has been three years since their last shot, said Col. Steve Jones, director of the Military Vaccine Agency.

Commanders will be responsible for working with health care providers and troops to ensure shot records are up-to-date and that those who qualify get their shots, Jones said.

The controversial vaccination program is mandatory for all personnel deploying to areas Pentagon officials have deemed “high risk,” and for those who already started the process. The department will not inoculate those exempt for health reasons, though exempted personnel still are deployable.

For security reasons, Pentagon officials won’t publicly define the high-risk areas, or say how many doses are available.

Anthrax vaccines were suspended in June 2001 because of a lack of vaccine when the manufacturer, BioPort, changed its manufacturing process without FDA approval. The stoppage created a stockpile shortage for the military. When the program resumed in 2002, it first started with troops deploying to the high-risk areas. With supply no longer an issue, the program can expand to include other troops, Jones said.

Some servicemembers have maintained the vaccine causes health problems and have accepted separation from service or disciplinary action for disobeying an order rather than take it

This summer, the Pentagon expanded the vaccination program in two phases. In June, as a result of an increase in supply, the Pentagon started inoculating “tens of thousands” of U.S. troops in or heading to the Pacific Command and Central Command areas.

In July, the program resumed for troops who already had received a dose before the program’s halt, regardless if deployed to a combat zone or stationed in the United States, Jones said.

Stars and Stripes requested information from the Department of Defense after seeing reports on the matter.

Since the June 2002 resumption, the department has inoculated about 840,000 personnel. Since the program’s inception in 1998, more than 1.2 million people have been vaccinated, he said.

In spite of the lag, troops do not have to start over with the regimen, experts said.

“We’re following guidance from the CDC (Centers for Disease Control and Prevention) … on immunization practices and they recommend to one, stay on schedule as close as possible, and two, if you miss [a dose] it is not necessary to resume the entire sequence. Start where you left off,” Jones said.

However, the shots are unnecessary, said Dr. Meryl Nass, a physician at Mount Desert Island Hospital in Bar Harbor, Maine, and an anthrax and bioterrorism expert who has testified repeatedly before Congress as a vocal opponent to the program.

“What is the evidence that there is a risk? There is none,” said Nass. “[Presidential candidates] Bush and Kerry both are beating the drums about the risk of bioterrorism, but every credible organization that has looked into the issue hasn’t found any,” she said. “There are no weapons of mass destruction [in Iraq] and two groups hand-picked to find them didn’t find them.”

But troops need the vaccine, Jones said.

“We still feel the threat remains,” Jones said. “We do not see a change in the threat and we think it is important to continue to provide a layer of protection to our troops and vaccinations is one of the primary layers of protection we can provide them.”

The CDC is conducting studies to determine if the six-dose regimen can be lowered to four. It hopes to submit data to the FDA in early 2005 that could change the route of administration to intramuscular and reduce the dose schedule to five doses, with the full study to change to four doses and possibly biannual boosters in late 2007.

October 19, 2004

Vaccine survey shows trouble at DAFB

Deleware News Journal

Troops vaccinated against anthrax at Dover Air Force Base in 1999 were more likely to get sick than those vaccinated elsewhere, according to research to be published next month. Walter Schumm, a professor at Kansas State University and a retired colonel in the Army Reserve, analyzed a 4-year-old survey by former Air Force Capt. Jean Tanner. In 2000, Tanner surveyed the troops in her unit in Dover and found that 32 percent who received the anthrax vaccine had such symptoms as severe joint pain, memory loss and arthritis.

"There was something at Dover Air Force Base that was different," Schumm said. He compared the rate at the base to the military's own estimates of adverse reactions to the vaccine worldwide.

Don Whitley, a major in the Air Force Reserve, said he may have filled out Tanner's survey. Whitley said he recalled talking with Tanner at the time and that she was troubled about the vaccine. Whitley received all six shots, and he reported his symptoms to military doctors.

"It was dismissed as not being part of the vaccine," he said.

Tanner could not be reached for comment.

Schumm's analysis is scheduled to appear next month in the medical journal Medical Veritas. His research has been published in several medical journals during the past 25 years. Schumm has a doctorate in family studies from Purdue University.

Pentagon spokesman James Turner said he was unaware of Schumm's research. He said the Defense Department believes the vaccinations administered in Dover were safe.

"We are very confident of the scientific assessments and conclusions that indicate no abnormal pattern of adverse events associated with anthrax vaccine when compared to other routine vaccines," Turner said.

Tanner mailed surveys to the home addresses of 252 members of her unit who received the vaccine in January 2000, according to Schumm's report. They were asked to list specific symptoms related to the vaccine.

The survey was mailed eight months after Col. Felix Grieder temporarily suspended the vaccination program at Dover. Grieder, who lives in Texas, now says his troops were used as guinea pigs in illegal medical experiments by the government at the base.

Grieder's troops received anthrax vaccine that may have contained squalene. Some experts say even trace amounts of squalene can suppress the immune system, causing arthritis, neurological problems, memory loss, miscarriages and incapacitating migraine headaches. The military has tested squalene on humans in Thailand and other foreign countries to boost the effect of some vaccines.

The military has conducted no specific research into the health effects of the vaccines administered in Dover. Tanner's is the only known survey of troops taken while they were receiving their series of six shots.

Military officials strongly deny conducting illegal experiments and deny a link between the anthrax vaccine and health problems.

Just over half of the members of Tanner's unit responded to the survey. She counted those who did not respond as not having reactions to the vaccine.

Schumm found Tanner's survey by researching the anthrax vaccine on the Internet.

While Schumm makes no mention of squalene in the article, he said those who received the vaccine in Dover at the time had an abnormally high number of reactions. The rate of adverse reactions to the vaccine varied according to what symptoms were considered adverse, he said.

For instance, 82 of the 252 subjects met the military's criteria for a systemic reaction to the vaccine, a rate of 32.1 percent. Using the stricter criteria established by the Centers for Disease Control and Prevention, 47 potential subjects had adverse reactions, a rate of 18.7 percent.

The military has estimated only 0.007 percent of military personnel experience adverse reactions to the vaccine. Throughout his research, Schumm said he has never encountered rates of adverse reactions approaching the rates at Dover.

The survey was not designed as a scientific experiment, Schumm said. Tanner did not have responses from a control group of people who did not receive the anthrax vaccine.

But Schumm said the military should have investigated the survey results because they were so striking.

"It's a 32 percent rate of reactions," Schumm said. "Even just out of curiosity, it should have led to an investigation."

In a letter sent Thursday to Secretary of Defense Donald Rumsfeld calling for an investigation into the anthrax vaccination program, Delaware's congressional delegation noted "a great deal of unnecessary confusion and anxiety has been caused by the handling of this issue." The military has said it is preparing a response.

In addition to the Defense Department, the delegation also called for an investigation by the Government Accountability Office, formerly known as the General Accounting Office, and the House and Senate Armed Services Committees.

"From what I've seen, more people have died from complications with the anthrax vaccine than have been killed by anthrax," Schumm said.

Several former Air Force personnel who received their anthrax vaccinations at Dover Air Force Base starting in 1999 reacted Monday to news that the number of people who experience adverse reactions to the shots at Dover was abnormally high. The study by University of Kansas Professor Walter Schumm is scheduled to be published next month.

Felix Grieder

Col. Felix Grieder, a former base commander, said he felt somewhat vindicated by news of Schumm's study.

Grieder has devoted the past five years to investigating the Dover vaccination program, and has concluded that his troops were used as guinea pigs.

"At a minimum, this research further highlights the need for a timely and thorough investigation," Grieder said.

Danny Tam

Danny Tam was a former Air Force security policeman who received his first anthrax vaccination at Dover. After the shots, Tam was medically discharged by the Air Force for migraines, which his medical records indicate were linked to the vaccine. Tam is considered 100 percent disabled by Veterans Affairs.

Tam said Schumm's research only confirms something he has known for a while - the anthrax vaccine is not safe.

"I think they should look into it more," Tam said. "They're not researching it, and there are going to be a lot more soldiers going through exactly what happened to me. I really appreciate those folks who are willing to step up and study it. All we're getting is a big runaround."

Barbara Welsh-Rosenblum

Retired Air Force Sgt. Barbara Welsh-Rosenblum blames the anthrax vaccine for five miscarriages. Her last duty station was Dover Air Force Base.

She said that if the Air Force wanted to conduct a study now, it would still be possible to find the personnel who received the vaccine at Dover.

"The Air Force is like a small family," she said. "They could locate the people who were there. It would take a bit of work, but they could do it."

Welsh-Rosenblum said she would cooperate with any study.

"I'd do anything so that no one has to go through what I did."

Jay Lacklen

Lt. Col. Jay Lacklen served as one of Grieder's C-5 pilots. Lacklen, who is now retired, suffers arthritis he believes was caused by the anthrax vaccinations he received at Dover.

Lacklan said the evidence of illness from the vaccine in Dover is so powerful that any serious investigation would uncover the problems.

"Compare that to all of the congressional committees, with all their money and subpoena powers," Lacklen said. "This one guy, one scientist, how did he make this discovery when all these people with money didn't?"

Lacklen pointed out that the government often cites the safety of the anthrax vaccine and several scientific studies supporting the efficacy of the vaccine on its Web site.

"These vaunted scientists go on and on about how effective and safe the vaccine is," Lacklen said. "Why didn't they know about this? Why won't the military allow further off-the-shelf testing of the vaccine? That would confirm or deny its safety right there."

Local airman crippled by Anthrax vaccine, Bonner joins fight

NBC 15

DAPHNE, Ala.) October 19 -- A local man attached to a Kentucky Air National Guard unit is confined to a wheel chair after receiving a military anthrax vaccination. The young man says Uncle Sam is now turning his back on him and many others who are having an allergic reaction to the vaccine.

Friends of 23-year-old Aaron Haycraft say he was the picture of health prior to March 2003. Haycraft was a part-time college student, a triathlete and earning more than $1,000 a week working as a mechanic. That all changed when the young man's Air National Guard Unit in Kentucky activated him 19 months ago. Haycraft was scheduled to be shipped off to Iraq, but an allergic reaction to an Anthrax vaccination left him confined to a wheel chair and suffering from more than a dozen medical problems including loss of vision and paralysis.

Aaron Haycraft told NBC 15's Leon Petite, "I think that 19 months is long enough. I'm no good to the military anymore. I'd like to go on, but in the last two weeks, two colonels have decided to cut my pay off."

Haycraft says he is just one of dozens of people in the U.S. Air Force that have had an allergic reaction to the vaccine. The young man says he was on active duty when the mishap took place, but so far the military has refused to give him a disability retirement. Haycraft says he has been evaluated by dozens of military and civilian doctors who all say he is disabled, but Haycraft says all it has done is amass hundreds of pages of military paper work.

Haycraft says the Air Force has refused to hear his case. Air Force National Guard Officials in Kentucky would not comment about Haycraft's case other than to say it is a long military process and they were acting in what they felt will be in Haycraft's best interest.

At least one government official feels Haycraft is getting the run around. U.S. Congressman Joe Bonner is actively pursuing the case in Haycraft's behalf. Bonner says after only one meeting with Aaron it is obvious to him that this young man has fallen through the cracks. The Congressman says his office will leave no stone unturned in their efforts to get him the benefits he so richly deserves.

Meanwhile Haycraft's childhood friend and his fiancee have moved to Daphne from Kentucky to take care of him. His friends have to feed him, bathe him and tend to him 24 hours a day.

One of those friends, Misty Lewis, said, "So for someone now to have to do everything for him, it's heartbreaking because he was intelligent and bright now he just sits in a wheel chair and wonders what life could have been like."

October 17, 2004

Fearful pilots reluctant to speak out

As Air Force personnel in Dover struggle with fears about the anthrax vaccine and tainted lots, active and retired military pilots also are frightened about another scenario: Being grounded.

Dozens of active and retired military pilots who fly commercially were afraid to speak out publicly when interviewed by The News Journal about the anthrax vaccine and squalene. They said their careers could be jeopardized if the extent of their illnesses was made known.

Pilots stand to lose a lot. In 2002, median annual earnings of airline pilots, co-pilots and flight engineers were $109,580. The median annual earnings of commercial pilots were $47,970.

Aviation medical examiners, on a contractual agreement with the Federal Aviation Administration, evaluate the health of pilots to determine whether they are physically and mentally capable of flying an airplane.

Pilots who fly for major airlines, known as Class 1 pilots, receive physicals every six months. Pilots who fly exclusively for private corporations, known as Class 2 pilots, may be required only to receive annual physicals.

If a pilot is exhibiting signs of autoimmune disease, he or she must instantly be grounded until further investigation, said Dr. John Hocutt Jr., a Wilmington-based aviation medical examiner. "Autoimmune diseases are very serious," he said.

Some civilian researchers, such as Dr. Pamela Asa of Tulane University, believe that trace amounts of squalene injected into the human body suppress the immune system, causing autoimmune disease. Former Dover Air Force Base commander Col. Felix Grieder has accused the military of running an illegal experiment on his troops by adding squalene to the anthrax vaccine.

As Hocutt conducts detailed examinations of the pilots - with an emphasis on vision and previous medical history - he also relies on how forthright they are about their health.

Hocutt has examined 2,000 to 3,000 pilots, several of them former Air Force pilots out of Dover who now fly commercially, in his 20 years as an aviation medical examiner. In that time, he has denied about 25 pilots from flying. According to the FAA, 3,444 pilots were denied their license for medical reasons in the United States in 2003. Data for Delaware were not available.

Arthritis and memory loss can be symptoms of autoimmune disease. Hocutt said it would be very difficult for a pilot who has severe joint pain and arthritis to pass the physical - even if they neglect to mention the symptoms on the physical's questionnaire. But it's possible that they could pass the physical if they suffered from intermittent memory loss.

"They could seem perfectly normal when they come in to see me. But if they don't tell me the truth on the form, it would be possible for them to get by," Hocutt said. "You have to be absolutely healthy to fly."

The perilous experiment, part one: Four survivors of the military’s anthrax vaccine

By John Byrne | RAW STORY

Promising lives shattered by anthrax vaccine

As an Air Force police officer, Kerri Dorsey worked twelve to fourteen hour days. She did physical training after work. She volunteered.

“When somebody’s wife had a baby, I did showers for them,” Dorsey says. “I did shop-with-a-cop programs where we took underprivileged kids to get gifts for the holidays.”

“I even held a second job as a DJ just for extra money,” she adds softly, “because you know we don’t make much.”

Now everything has changed. It has been six years since the 28-year-old Floridian got her fourth anthrax vaccine shot – there are six in the initial series – and she has since developed muscular sclerosis. She walks with a cane, and finds it hard to remember ordinary things, like grocery lists.

“I know I’m supposed to go the grocery store,” she says, “but when I get there I can’t remember those three things I need.”

Dorsey is not alone. RAW STORY has spoken with other servicemembers whose promising careers have been truncated by the vaccine. Dozens more have shared their personal tragedies with news organizations around the country.

Another study the same year, commissioned by Congress and paid for by the Defense Department, and is regularly used by the Pentagon and the manufacturer, came to other conclusions.

The National Academy of Science’s Institute of Medicine study found the vaccine to be “sufficiently safe,” though they stated that a new vaccine was “urgently needed.”

“The most prudent course of action is to develop a new vaccine,” said committee chair Brian L. Strom, a professor of medicine at the University of Pennsylvania School of Medicine.

The report did not identify any unexpected short-term adverse reactions to the anthrax vaccine.

Yet hundreds of soldiers have suffered permanent afflictions as a result of the vaccine. The military, however, continues to assert that it is safe and has court-martialed those who refuse to take it since it was required for all troops in 1998.

The Pentagon’s anthrax vaccine website, anthrax.mil, has a tagline, “a matter of health, a matter of trust, a matter of national security.”

“Your health and safety are our number one concerns,” the site claims. “The anthrax vaccine is safe and effective.”

Six servicemembers filed suit in March 2003 against the Defense Department questioning the mandate for an unsafe vaccine. That case is awaiting a final ruling.

Dorsey asserts she noticed early warning signs after taking the shots. Doctors brushed her concerns aside, she says.

After the first shot caused an allergic reaction, and the second and third injections caused flu-like symptoms and diarrhea, the Air Force slated her for the fourth in the series. This time Dorsey had more than an allergic reaction – she went into anaphylactic shock.

“I thought I was gonna die for a minute there,” she says.

But being on the verge of death wasn’t enough for her military doctors to cancel the rest of the shots.

“They said they could not prove that it was from the vaccine even though my doctor said it was,” she says. “The higher ranking doctor said it wasn’t because they didn’t want the stigma from the vaccine.”

So she dodged the fifth shot, claiming she was pregnant (she wasn’t). Soon thereafter, she was retired from the military for more serious health ailments. The service tried to reduce her disability payments as much as possible.

Even though it was clear her condition wouldn’t allow her to keep a steady job, they offered her a scant 30 percent disability. She fought, and got 50 percent. The Department of Veterans’ Affairs later qualified her for 100 percent, 70 percent of which was tagged directly to her MS.

In February of 2001, while skiing in Montana, the whole left side of her body went numb. That June, she went blind. Each of these incidents, known as MS exacerbations, were temporary. But her condition is not.

“I have to take a nap every single day,” she says. “I’m so wore down. I take a shot three times a week for my MS, usually in my stomach or my legs. I take a pill every morning. I have a son who is going to be three in December.”

Disabled by vaccine, he’s recalled to serve

Jason Cordova was a jumpmaster; he helped soldiers jump out of planes. He was an Army captain and a communications detachment commander for the Special Forces.

Now he has pain in the lymph nodes of his groin, and trouble urinating. His diagnosis? Nobody knows.

Cordova says he’s seen urologists and infectious disease specialists six to ten times. The VA gave him a 10 percent disability, linking it directly to the anthrax vaccine.

“I can still feel where I got the shot, even after four years,” Cordova says.

On June 21, he was recalled to Operation Enduring Freedom, an operation primarily focused in Afghanistan. Cordova says he expects the Army will medically exempt him from the further vaccine shots, though he doesn’t understand why they would send him into what the Army has classified a high-threat area without protection.

“How can all of the soldiers at the left, right, rear and front require it and why don’t I?” he asks.

“How about the fact that if I get called back into active duty my disability benefits stop?” he queries, his voice rising. “How absurd is that?”

Cordova penned letters to his local officials. He wrote to his senator, Arlen Specter (R-PA), who is the chairman of the Veteran’s Affairs committee in the Senate.

“This is about leadership, principle and trust in our government,” he wrote. “If I can’t be adequately protected from a deadly risk of infection — as described by the highest levels of government — how could it be legally, ethically and/or morally justified to deploy anywhere without a life-protecting vaccination?”

Last Thursday, Sen. Specter’s office told him that they had submitted an inquiry to the Army on his behalf.

“If I got called up for Operation Enduring Freedom and it didn’t require being in an area with a high risk of anthrax exposure I would have boots on the ground immediately,” he says. “I would be there in a heartbeat.”

Cordova notes he has a George W. Bush sign in his front yard, and that he supports the global war on terror. He says his concern regarding the vaccine isn’t about politics.

“I support the president. This isn’t about left or right,” he says. “This is about right or wrong.”

Bitterness and suspicion

Dwayne Fitzpatrick says he never knew he was getting the anthrax shot.

“I didn’t even know I got the first one,” Fitzpatrick says.

He claims that the vaccine’s application was slipshod, and not always documented. He coughs sometimes as he speaks.

“I know guys who have gone into tents and have gotten shots and it was written in a document but wasn’t transferred to their records,” he states.

“I’ve known people that got six or seven before,” he adds. “They forgot to write it down.”

Since he got his fifth shot, Fitzpatrick has experienced pain all over his body, coughs and memory loss. A civilian doctor confirmed in 2003 that his illness was “associated with the anthrax vaccination,” and a military doctor in 2004 that his cognitive deficits were “secondary to anthrax vaccination.”

“After each shot I got this huge lump and broke out in a fever, and was just sick for days,” he says.

Fitzpatrick rattles off a list of 25 medications he’s been on, including anti-depressants he says he didn’t even know he was taking. The list reads like that of a senior citizen’s – naproxen, Vioxx, Ambien, Trazadone, Celebrex, Lexapro – though he’s just 43.

“I was given sleeping pills over in Saudi Arabia,” he says. “I was over there for almost four months. I was supposed to be over there for six months but the Air Force doctor felt so bad for me that he requested I go back to the U.S.”

Before the shots, Fitzpatrick says he was a runner, a biker and a swimmer. Now he’s too weak to do much of anything. But he’s more worried about his memory loss.

“It took me three months to remember my Army password,” he confesses. “Three months of repetitions to remember my own password.”

“The pain thing, I’ll get used to,” he says, “but the memory thing – I’ll never get used to that.”

Fitzpatrick says he’s angry at the company that made the vaccine, and the military for requiring it. The military accepts the idea of collateral damage, even if it applies to their own troops, he asserts.

“If it protects ten people and it kills one,” he says, “that’s acceptable losses.”

Twenty-two, and unemployable

Michael Girard, also a military police officer, used to work twelve to fourteen hour days.

“Now a day for me consists of rolling out of bed in the morning and lying on the couch,” he says. “That’s about it.”

Twenty-two, Girard lives in constant pain. Just over a year after his enlistment, he was discharged from the Air Force with a 100 percent disability. Veterans’ Affairs will give him money to support him, his wife and his fifteen-month old son for the rest of his life.

According to military doctors, the source of his disability was a “temporal reaction to the anthrax vaccine.”

Girard, too, says he was never told he was getting the vaccine.

“The first shot I had wasn’t even in the medical clinic on base, it was in the education center, in the auditorium,” he says. “They said, “Roll up your left sleeve,” and just stuck us.”

Shortly after his fifth shot, Girard developed pain all over his body. He has suffered pain in his groin, stomach, head, knees and joints for the two years since he got his last shot. He also experiences dizziness.

When he told commanders that he thought his condition resulted from the shots, they cut him off financially and told him not to speak out.

“I would get calls from my first sergeant telling me to keep my mouth shut,” he says.

Girard has upcoming appointments with a gastrointestinal specialist and a neurologist, but doubts that anything will come of it.

“I still hope one day that I won’t wake up in pain,” he says, “But I guess there’s just a certain extent to which you can hope.”

“Who’s gonna want to hire a guy who can some days barely get out of bed?”

Coming later this week: The firm that manufactures the vaccine claims it produces no adverse health effects. They’ve convinced the U.S. conference of mayors to put pressure on the Health and Human Service Department so the vaccine can be approved for civilian use. They sent marketing delegations to all three of the presidential debates. Just how far will a company go to make money, and how do they respond to charges their vaccine is unsafe?

October 15, 2004

Four inquiries into anthrax allegations demanded

By LEE WILLIAMS and HIRAN RATNAYAKE The News Journal

Del. delegation gives Rumsfeld month to report on squalene use

Delaware's congressional delegation officially called for four investigations Thursday into allegations that Dover Air Force Base pilots and crews were used as guinea pigs to test experimental anthrax vaccine.

Sens. Joe Biden and Tom Carper and Rep. Mike Castle jointly sent letters, calling for separate investigations to Secretary of Defense Donald Rumsfeld, the chairs of the House and Senate Armed Services Committees and the comptroller general of the Government Accountability Office.

"At a minimum, a great deal of unnecessary confusion and anxiety has been caused by the handling of this issue," the letter to Rumsfeld states. "At a maximum, intentional actions or unintentional incompetence may have created a health hazard for our personnel."

The letter to Rumsfeld gives the defense secretary until Nov. 15 to provide a detailed report.

"I'm happy. It's five years late, but well done," said retired Lt. Col. Jay Lacklen, a former Dover C-5 pilot whose health was affected by the shots.

"It's a good first step, but they should halt the vaccination program while they're conducting the investigation," Lacklen said.

Pentagon spokesman Jim Turner said he could not comment because he hadn't seen the letters Thursday evening. The military has denied it tested an illegal vaccine on troops in Dover.

In a written release, the lawmakers cite recent media reports for raising concerns about the vaccination program.

Problems began at Dover in May 1999 after some troops in their 20s and 30s began developing illnesses normally associated with old age.

The News Journal reported Sunday that a former Dover commander, retired Col. Felix Grieder, concluded that his troops were the subjects of illegal experiments at the base. The troops received anthrax vaccine that may have contained squalene.

Neither the military nor the FDA test for squalene, a substance that occurs naturally in the body and has been used to boost a vaccine's effect. Some experts say even trace amounts of squalene can suppress the immune system, causing arthritis, neurological problems, memory loss and incapacitating migraine headaches.

In their letter to Rumsfeld, the lawmakers focused on several issues raised in The News Journal report.

"As part of resolving this issue, we would like to know the results of the research we understand the Department has done on the effects of squalene in vaccines," the letter states. "In addition, it is important to explain the rationale for the Army's decision to seek a patent for a new anthrax vaccine that includes squalene."

Grieder halted the vaccination program in 1999, a move he said brought an end to his military career. Testing by the Food and Drug Administration detected squalene in varying amounts in the vaccine. The substance was detected in all the vaccine sent to Dover, but not in vaccine sent to other military installations.

The Air Force and the Department of Defense have continually stressed the safety of the vaccine, despite the claims of military personnel who say it made them ill.

The military has secretly experimented with squalene to test its ability to boost the effectiveness of some vaccines. The Department of Defense has admitted conducting tests on humans using squalene in vaccines in Thailand. But the military said any contamination in the vaccine in Dover must have occurred accidentally.

The military has said it suspects that the FDA conducted faulty tests and that the vaccine contained no squalene. It also contends that the amounts of squalene the FDA said were contained in the vaccine would have been too small to affect human health.

Pentagon not listing 17,000 war casualties

by Mark Benjamin UPI

WASHINGTON, Sept. 15 (UPI) -- The Pentagon has nearly 17,000 service members medically evacuated from Iraq and Afghanistan not listed on their public casualty reports.According to military data reviewed by United Press International those evacuees appear to fit the Pentagon's own definition of war casualties.

The military has evacuated 16,765 individual service members from Iraq and Afghanistan for injuries and illnesses not directly related to combat, according to the U.S. Transportation Command, which is responsible for the medical evacuations. Most are from Operation Iraqi Freedom.

But the Pentagon's public casualty reports, available at www.defenselink.mil, list only service members who died or were wounded in action, even though the Pentagon's own definition of a war casualty is: "Any person who is lost to the organization by having been declared dead, duty status - whereabouts unknown, missing, ill, or injured."

In addition to those evacuations, 32,684 veterans from Iraq and Afghanistan now out of the military sought medical attention from the Department of Veterans Affairs by July 22, according to VA reports obtained by UPI. The number of those visits to VA doctors that were related to war is unknown.

October 14, 2004

Mishandling of anthrax at the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md., in the wake of the 2001 anthrax attacks, has raised safety concerns about proposed biodefense facilities that would handle dangerous microbes, USA Today reported today (see GSN, April 30).

Bruce Ivins, a biodefense expert involved in Operation Noble Eagle — the U.S. response to the Sept. 11, 2001 attacks and the subsequent anthrax mailings — recounted a December 2001 incident at the laboratory in which his officemate complained about careless handling of samples that could be tainted with anthrax.

“I swabbed approximately 20 areas of (her) desk, including the telephone computer and desktop,” Ivins told Army investigators. Half of the samples “were suspicious for anthrax,” he said.

Ivins said he disinfected the desk and did not report the incident to his superiors.

“I had no desire to cry wolf,” he later told an Army investigator.

Such incidents were part of a larger pattern of mishandling of the pathogen, according to a 361-page U.S. Army report on the events of late 2001 and early 2002 at the institute.

The six-member team that worked in the USAMRIID lab that handled anthrax was increased to 85 researchers in the wake of the attacks that killed five people. Most of the new workers had to learn to handle the pathogen “on the fly,” according to USAMRIID’s commander, Col. Erik Henchal, who led the forensic effort.

Up to 70 researchers slept in cars or on cots to keep up with the workload, USA Today reported. Over the course of approximately eight months, the lab tested 30,000 suspicious envelopes, packages and other items. Researchers also tested about 320,000 environmental samples from locations such as the Hart Senate Office Building and Washington, D.C.’s Brentwood postal center.

“They were running just fantastic numbers of (anthrax) samples,” said biodefense expert D.A. Henderson of the University of Pittsburgh. “I’m not sure what they have accomplished is appreciated.”

Three strains of anthrax were found to have escaped from the Biosafety Level 3 laboratory in April 2002. Continued testing uncovered contamination in three other areas, including the office used by Ivins. Roughly 90 laboratory personnel were tested for exposure to anthrax, but no one became ill.

“The good news is nobody got the disease,” said Alan Zelicoff, a biodefense expert and consultant. “The bad news is that nobody got the disease because just about everybody near the BL-3 suite had been vaccinated.”

Such difficulties increase concerns about other proposed biodefense labs, some experts have said. About 50 maximum-containment labs nationwide harbor the deadliest bacteria, viruses and toxins, according to USA Today, and 40 new biodefense research labs are planned in cities such as Atlanta and Boston.

“The message here from a scientific and policy standpoint is profound,” said Zelicoff. “Facilities that are medical and microbiological may not be suitably equipped for dealing with aerosolized versions of the organisms that they otherwise deal with in great safety. ... These facilities probably ought not be located in a heavily populated area. How do you contain smoke?”

Accidents are rare and the kind of work deluge the Fort Detrick laboratory faced after the attacks is unlikely to be a factor in the future, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

“Most scientists do things in a very careful way,” Fauci said. “The chance that they’ll be working in the same rushed atmosphere they faced at Fort Detrick is very small” (Barbrow/O’Brian, USA Today, Oct. 14).

October 13, 2004

Castle insists on response from military, Pentagon asserts vaccine program safe to continue

By LEE WILLIAMS and HIRAN RATNAYAKEThe News Journal

Defense Department officials haven't decided whether they'll cooperate with a request by Delaware's congressional delegation to investigate the anthrax vaccination program at the Dover Air Force Base.

They also expressed confidence that the controversial vaccination program should continue at Dover and throughout the military despite safety concerns.

Sens. Joe Biden and Tom Carper and Rep. Mike Castle on Tuesday were finalizing a joint letter to Secretary of Defense Donald Rumsfeld and the chairmen of the House and Senate Armed Services committees requesting an investigation into whether troops in Dover were used as guinea pigs in illegal experiments starting in 1999.

Castle said Tuesday the Air Force won't have a choice about whether to cooperate.

"There is no way they can ignore a letter from two senators and a representative," Castle said. "They can try to soft-pedal their response. We'll get their response and make a judgment about how good a response it is."

Castle said it may be necessary to call for an independent investigation.

"It may be we need an independent study similar [to], but not as large as, the 9/11 Commission report," he said. "If they choose not to be responsive, why not go the next step, and have the legislative or executive branch bring it out?"

Retired Air Force Maj. Hans Reigle was one of 55 pilots who left a reserve air wing at Dover rather than take the anthrax vaccinations.

Reigle ended his 20-year career in a nonflying staff position, for which the shot wasn't required. He said he hopes an investigation will restore the government's credibility and bring closure to the issue.

"Their word needs to become their bond," Reigle said. "They need to get rid of this Agent Orange perception, so when they tell you something's safe, you can believe them. That's when we'll know we have a good military."

The News Journal reported Sunday that a former Dover commander, retired Lt. Col. Felix Grieder, concluded after years of investigation that his troops were the subjects of illegal experiments at the base. The troops received anthrax vaccine that may have contained squalene. Some experts say even trace amounts of squalene can suppress the immune system, causing arthritis, neurological problems, memory loss and incapacitating migraine headaches.

Grieder halted the vaccination program, a move he said brought an end to his military career. Subsequent testing by the Food and Drug Administration detected squalene in varying amounts in the vaccine. The substance was detected in all the vaccine sent to Dover, but not in vaccine sent to other military installations. The military no longer tests for squalene, a substance that occurs naturally in the body and boosts a vaccine's effect.

Lt. Col. Frank Smolinsky, a spokesman for the secretary of the Air Force, stressed the safety of the vaccine, despite the claims of military personnel who say it made them ill.

"The FDA has approved the vaccine for use by the U.S. military, and we stand by the safety and effectiveness of the vaccine. We believe it is an effective force protection measure," Smolinsky said. "There is no reason not to continue the anthrax vaccination program."

Maj. Cheryl Law, Dover Air Force Base's public affairs chief, said the vaccination program is continuing at the base.

Pentagon spokesman Jim Turner said the Department of Defense has not received a formal request for an investigation. The Air Force surgeon general's office pledged its help with any inquiry, but Smolinsky and Law said no decision has been made on whether to cooperate with the delegation's request.

The military has secretly experimented with squalene to test its ability to boost the effectiveness of some vaccines. The Defense Department has admitted conducting tests on human subjects using squalene in vaccines in Thailand. But the military denies it tested squalene in Dover and has said any contamination in the vaccine must have occurred accidentally.

Problems began at Dover in May 1999, after some troops in their 20s and 30s began developing illnesses normally associated with old age.

The military has said it suspects that the FDA conducted faulty tests and that the vaccine contained no squalene. It also contends that the amounts of squalene the FDA said were contained in the vaccine would have been too small to affect human health.

The effort to develop countermeasures to biological terrorism, many scientists say, faces a looming problem on the horizon: a critical shortage of monkeys needed for testing.

Three years after the anthrax attacks that killed five people and injured dozens of others, many involved in biodefense research say the country does not have a large enough supply of non-human primates for the kind of massive research effort that would be needed in the aftermath of another bioterrorist attack.

“Today it is an area of concern,” said Michael J. Hopmeier, a special adviser to the U.S. Surgeon General, the Pentagon’s Defense Advanced Research Projects Agency (DARPA) and other government agencies. “In the near future, it’s going to be a significant problem.”

Testing vaccines to defend against bio-terror agents — such as anthrax, smallpox and even monkeypox — is too dangerous for human subjects. DARPA, long a leader in over-the-horizon scientific projects, is working to construct synthetic systems to duplicate human organs and immunology for such tests, but they are still far from producing results needed now, researchers say.

Thus the development of countermeasures to biological agents, many scientists say, rests largely on the shoulders of the monkey, the animal whose biology most closely resembles that of humans.

A rule developed by the Food and Drug Administration (FDA) in 2002 allows the approval of new drugs and products based solely on animal studies, in cases where clinical trials in humans are unethical or unsafe.

Biodefense researchers say they have enough monkeys for current projects. But many say no contingency stock is available to supply the kind of immediate and unexpected push for a new inoculation necessary in the wake of a bioterrorist attack.

“To me, we don’t have any surge capacity,” said C.J. Peters, director for biodefense at the University of Texas Medical Branch Center for Biodefense and Emerging Infectious Diseases.

Supply and Demand

The price of monkeys has risen with the drop in supply and a consistent and growing demand, Peters noted.

In the late 1980s, individual rhesus macaque monkeys cost several hundred dollars each. Now, Peters said, the price is $3,000 per monkey. Other researchers priced each monkey even higher.

The National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH) that supports biomedical research, has three breeding colonies with about 350 rhesus macaques available for testing in fiscal 2005.

But director Judith Vaitukaitis said all of those monkeys are dedicated to AIDS research.

Other government agencies contacted for this story were unable to furnish a comprehensive accounting of the nation’s supply of non-human primates for biodefense research.

That, many researchers say, is exactly the problem.

Government funds — primarily NIH grants — pay only for the monkeys required for specific, ongoing research projects. To date, no macro analysis has been conducted to determine how many non-human primates are currently available across the country and how many would be needed for vaccine development in response to a bioterrorist attack.

“In general, I do not believe the administration or the general research community as a whole really understands or has a clue just how important this is,” said Hopmeier.

“It’s not as fun as having a new vaccine. . . . But it’s absolutely vital to everything we do. In general, there just isn’t enough attention paid to this,” he added.

Existing research facilities lack the room to house the likely number of monkeys required, Hopmeier and others agreed. Two National Biodefense Laboratories currently under construction will become the first workspaces dedicated exclusively to researching emerging threats in biodefense.

Although these facilities may house more monkeys, organizations also suffer from a shortage of qualified personnel to perform high-level biodefense research, researchers say.

China Syndrome

Hopmeier and others involved in biodefense research say the post-9/11 demand for such animals comes at a time when circumstances have limited the supply of monkeys.

The number of imported animals, they say, has decreased, particularly after the severe acute respiratory syndrome epidemic in China, a major exporter of rhesus macaques. Meanwhile, the majority of Indian-born rhesus monkeys have been earmarked for AIDS research. And efforts to generate more monkeys are limited by the fact that the animals are not prolific breeders.

NCRR’s Vaitukaitis acknowledged a limited supply of available rhesus macaques but strongly denied a looming biodefense shortage, saying researchers can use other species of monkeys, which are more readily available.

But Peters, of the University of Texas, said the rhesus macaque is the preferred monkey because scientists know the most about it. Others agreed with his assessment that the looming shortage is real.

“The shortage of animals is, as of this moment, not holding back biodefense, but as you move down the line it will be a big issue,” said Andrew Lackner, director of the Tulane National Primate Research Center.

“To build up the animal facilities and animal resources is also going to take years. If everyone sits around and waits until [the laboratories] open their doors, [the shortage of] non-human primates is going to become a major roadblock.”

Officials from NIH, the FDA, the Department of Defense and other agencies should meet to quantify the national need and start fulfilling it, Peters said.

“We should put that breeding into place so we have a floor under the needs,” he said. “I don’t like to work with rhesus. . . . But I’d much prefer to work with them than [with] woman and children.”

October 12, 2004

Delaware's congressional delegation on Monday called on military officials to investigate whether the Defense Department used troops as guinea pigs to test illegal anthrax vaccinations at the Dover Air Force Base in 1999.

Sen. Joe Biden, Sen. Tom Carper and Rep. Mike Castle said they will send aletter to Secretary of Defense Donald Rumsfeld asking him to look into theallegations. They also said an outside investigation may be necessary.

The News Journal reported Sunday that former base commander Col. FelixGrieder concluded after years of investigation that his troops were the subjectof illegal experiments in Dover. The troops received anthrax vaccine that may have

The military has secretly experimented with squalene to test its ability toboost the effect of some vaccines. But the military denies it tested squalenein Dover and has said any contamination in the vaccine must have occurredaccidentally.

"If it was intentional, I want to see people go to jail," Biden said. "I amoutraged if it's intentional."

In addition to the letter to Rumsfeld, Biden wants investigations by theHouse and Senate Armed Services Committees and the Government AccountabilityOffice.

"I want to know, if it was intentional, what compensation will take place;and if it was negligence, who was responsible and what the federal governmentwill do," Biden said.

Castle said an independent investigation by a presidential or legislativecommission may be necessary.

"We may need to appoint individuals with medical knowledge and no vestedinterest," Castle said. "We may need an outside agency beyond the military."

Carper said, "It may well also be prudent to ask for an independentinvestigation by the GAO, as well as by the House and Senate Armed ServicesCommittees. The bottom line is we need to take these allegations seriously and follow up diligently, and we will."

Ex-pilot wants action

Col. Jay Lacklen, a retired Dover pilot who has spearheaded a publicawareness campaign about problems at Dover, has seen congressional hearingsfocused on problems with the anthrax vaccine. Despite huge staffs, subpoena power andcongressional prestige, the hearings accomplished little, Lacklen said.

"Now, if they go in armed with the questions they really need, such assqualene, and if they can just make someone talk, I'll be happy," said Lacklen,who suffers from debilitating arthritis he believes was caused by squalene in theanthrax vaccine he received.

Problems began at Dover in May 1999, after some troops in their 20s and 30sbegan developing illnesses normally associated with old age.

Grieder, the former base commander, halted the vaccination program, a move hesaid brought an end to his military career. Subsequent testing by the Foodand Drug Administration detected squalene in varying amounts in the vaccine.

The substance was detected in all the vaccine sent to Dover, but not in vaccinesent to other military installations. The military no longer tests forsqualene.

The military has said it suspects that the FDA conducted faulty tests andthat the vaccine contained no squalene. It also contends that the amounts ofsqualene the FDA said were contained in the vaccine would have been too smallto affect human health.

However, a group of civilian scientists led by Pamela Asa of TulaneUniversity has conducted two studies that found evidence of squalene injectionsin the blood of troops. The scientists also say trace amounts can cause harm.

Castle said he was struck by the age of the troops reporting medical issuesthey said were caused by the anthrax vaccine.

"I am very concerned about the young people getting this," Castle said."We're dealing with fit individuals in the military. Secondly, they're used tohardships. If they say they're sick, it's very real."

History of secret tests

Government officials have acknowledged that the Department of Defensesecretly tested squalene on human beings in Thailand. Grieder believes they didthe same in Dover. In a March 1999 report, the GAO accused the Defense Departmentof a "pattern of deception" and said the military confirmed human testsinvolving squalene only after investigators found out about them.

The Defense Department made anthrax inoculations mandatory for allactive-duty military personnel in 1998. The immunization order remains ineffect today, and more than 1.9 million troops have received the inoculations.

Officials at Dover Air Force Base and at military offices in Washington wereunavailable Monday because offices were closed for Columbus Day.

Experts Call for New Approach to Biodefense

By Joe FiorillGlobal Security Newswire

WASHINGTON — Top experts see important gaps in U.S. President George W. Bush’s largest biological-defense initiative and believe a fundamentally different approach is needed, according to a study released today (see GSN, Oct. 4).Project Bioshield does not address the threat of an attack using biologically engineered pathogens, according to 30 biological-defense leaders in the government, the drug industry and the academic world who were interviewed for the study by University of Pittsburgh and Sarnoff Corp. researchers.

Instead of seeking to spur development of specific drugs to fight existing agents, the experts said, Washington should invest massively in an effort to speed the processes by which new drugs are developed.

“The experts recommend that government, academia and private enterprise unite to create a new system to develop and approve antidotes quickly and affordably,” the authors wrote. “This is a major challenge, requiring interagency cooperation, coordination with dozens of entities and significant resources. It’s an effort on par with our push to put a man on the moon. But study participants believe such an effort is necessary because of the certainty and magnitude of the threat.”

The experts unanimously called a biological attack on the United States “a certainty,” with some expecting a strike using an existing agent and others predicting a new pathogen would be used. The researchers indicate biological engineering of new pathogens is considered “easy,” anonymously quoting one interviewee as saying, “Any high-school student can create genetically engineered organisms, so I think they will come.”

As a result, the experts believe “that an ‘organism-by-organism’ approach is not an effective long-term strategy for countermeasure development,” according to the study.“The number of potential threat agents (and engineered agents) is much too large to have a ‘one-bug-one-drug’ approach. In the long term, new paradigms for countering infectious disease will be needed, and the overall drug-development process must be shortened,” the researchers wrote.

Development of a new drug currently takes more than a decade and costs $800 million, according to the study. The researchers did not specifically ask the experts how much time and cost could be trimmed from those figures, but one of the study’s authors, Sarnoff Senior Vice President for Government Operations Mark Lister, said yesterday in an interview that a reduction of “one to two orders of magnitude” is possible.

In calling for a program to shorten “bug-to-drug” times, the experts echoed the views of some House of Representatives Democrats, who in May introduced legislation to create such a program (see GSN, May 5). The Senate is contemplating legislation known as Bioshield II that would also address some of the weaknesses identified in today’s study.

According to the study, “many” of the interviewees favor a “one-stop shop,” either wholly or partly within the government, to implement their recommendations. The entity would coordinate the new strategy and serve as a clearly defined, single interlocutor for the industry.

Lister said the first step should be a “system analysis” of the current drug-development process, with an eye to speeding the process. Because of its experience in conducting such analyses and its familiarity with biological defense, he added, the Defense Department should take the lead.

Bioshield Has “No Impact,” Says Industry Figure

The interviewees not only faulted Bioshield’s lack of focus on overarching processes, but also said the program would do little to spur drug development anyway. Bioshield is intended to promote new development by creating a government-supported market for otherwise unprofitable countermeasures.

“Frankly, I don’t see a whole lot of support” for Bioshield among drug makers, Lister said. “Government doesn’t completely understand the market drivers that confront people in industry.”

The experts said drug makers would be dissuaded from responding to Bioshield by uncertain profits and the potential for huge lawsuits.

“Bioshield has no impact on us as an industry,” the authors quote one industry leader as saying. “What? Are they going to help us with purchasing? What would drive me to put a team on antibiotics when my commercial people are saying, ‘Don’t do it, there is no return on investment on it’?”

Some interviewees recommended more government incentives to drug makers, potentially including direct government funding of companies’ research and stronger market and price guarantees, to spur new countermeasure development.

The experts also identified potential liability for harm caused by new drugs as an obstacle to drug-maker interest in countermeasure development. “That’s first and foremost on the minds of people in industry,” Lister said.

Since testing for countermeasures developed under Bioshield will probably be done on animals, the researchers wrote, “It is possible that the first time that a countermeasure is used in humans — possibly on thousands or even millions of people —would be during a crisis. This scenario has the potential to expose the developer to a significant level of liability because of side effects or lack of efficacy in humans, and many firms are unwilling to shoulder that liability exposure on their own.”

The 30 experts interviewed were listed in the study, and direct quotations from them were included without attribution by name. The experts included the director of the Johns Hopkins Bloomberg School of Public Health’s Center for Immunization Research, Donald Burke; GE Healthcare Technologies President Joe Hogan; the acting deputy assistant to the defense secretary for chemical and biological defense, Klaus Shafer, and a former occupant of the post, Anna Johnson-Winegar; Science Editor-in-Chief Donald Kennedy; former Merck Chief Executive Officer Roy Vagelos; and acting Food and Drug Administration Deputy for Operations Janet Woodcock.

October 10, 2004

Ex-DAFB commander says troops used as guinea pigs

By LEE WILLIAMS and HIRAN RATNAYAKEThe News Journal

Military denies that illness of pilots, crew caused by squalene. A former Dover Air Force Base commander says military officials used his troops as guinea pigs in illegal medical experiments under the government's controversial anthrax vaccination program.

After some of his troops in their 20s and 30s began developing arthritis, neurological problems, memory loss and incapacitating migraine headaches, Col. Felix Grieder took a drastic step. In 1999, he halted the vaccination program in Dover, a move he said ended his military career. The decorated Air Force colonel has spent the past five years trying to discover the truth about the vaccine program in Dover, where he commanded 4,000 troops.

Grieder has interviewed scores of his former pilots and crew who say they have had life-altering reactions to the vaccine.

"They would have no reason to lie. I believed them," he recalls. "I wanted to talk to them face to face."

Dover is now ground zero in the controversy because troops there were injected with anthrax vaccine containing squalene, a fat-like substance that occurs naturally in the body. Squalene boosts a vaccine's effect, but some scientists say injecting even trace amounts of it into the body can cause serious illness.

Government officials have acknowledged that the Department of Defense secretly tested squalene on human beings in Thailand. Grieder believes they did the same in Dover.

In a March 1999 report, the General Accounting Office accused the Defense Department of a "pattern of deception" and said the military confirmed human tests involving squalene only after investigators found out about them.

The Department of Defense says vaccine sent to Dover was accidentally contaminated with squalene. Grieder and other officers believe, however, that it was intentionally introduced to test pilots and crew in Dover.

The Defense Department made anthrax inoculations mandatory for all active-duty military personnel in 1998. The immunization order, which remains in effect today, calls for six shots over an 18-month period. Defense officials deny that military personnel were illegally used as guinea pigs to test a vaccine containing squalene.

But a /News Journal/ investigation raises significant questions about the military's denials and the safety of the vaccine:

. Of the first 50 batches of vaccine distributed worldwide for the mandatory inoculations, only five contained squalene - and those were all shipped to Dover. After denying for more than a year that there was squalene in the vaccinations given at Dover, the Air Force admitted in 2000 that it had been wrong.

. The five batches of vaccine sent to Dover contained increasing concentrations of squalene, Food and Drug Administration tests show. Some scientists say the pattern of squalene concentration could indicate that the military was measuring the troops' response to different dosages. Professor Dave Smith, a microbiologist at the University of Delaware, is one: "I'm certainly not saying they did or didn't do it. But you have to ask yourself, if you have five data points like that, what are the odds of that happening?"

. The Defense Department has rejected the evidence that the vaccine ever contained squalene. It has steadfastly contended that FDA technicians introduced squalene into the vaccine test via a "dirty fingerprint." The FDA has refused to explain its laboratory procedures for the tests. The military has never retested its stockpile of vaccine for squalene, claiming that, even if the amounts of squalene detected by the FDA were accurate, the concentrations were too low to affect human health. The department continues to require the vaccination for all military personnel - active duty, reserve and National Guard.

. Tulane University professor Robert Garry testified before Congress that even trace amounts of squalene injected into the human body suppress the immune system. In an interview with The News Journal, he said the body's response can cause some young and middle-age people to get illnesses normally associated with aging.

. Tulane University professor Pamela Asa and Baylor College of Medicine professor Dorothy Lewis have concluded that squalene's possible links to serious human illnesses should be studied further. The military has dismissed Asa's studies as inconclusive, although it has conducted no follow-up research on the health effects of squalene.

*Troops' consent required*

Military and international law expressly forbid experiments on troops without their informed consent. Federal law prohibits the testing of any drugs on human beings without approval by the Food and Drug Administration.

An estimated 1.9 million service members have received anthrax vaccine. Experts disagree widely over how many of them have experienced ill effects from the vaccine. Estimates range from 0.007 percent, or 13,000 people, by the Air Force to 84 percent, or 1.6 million people, by the GAO.

The military has generally refused to discuss details about the Dover vaccine that contained squalene. Air Force officials in Dover recently directed troops not to discuss their experiences with reporters. The News Journal spoke to dozens of Air Force pilots and crew members, but only a handful were willing to come forward publicly.

Military personnel said they were afraid they could face a court-martial for speaking publicly because it would violate an order to keep silent. Former military personnel, many of whom have taken jobs with commercial airlines, said they could lose their jobs if the extent of their illnesses became known.

Military spokespeople refer all inquiries to a Web site - called the Anthrax Vaccine Immunization Program or AVIP - that contains unsigned articles and information from unidentified sources. Civilian scientists such as Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said the Web site lacks scientific credibility.

The military says there is no link between squalene, the vaccine and the illnesses reported by servicemen and servicewomen. But military medical records of two Dover servicemen reviewed by The News Journal link all three, and some troops have received medical waivers from receiving future shots.

In February 2003, doctors at Walter Reed Army Medical Center wrote in a medical assessment of Senior Airman Daniel Tam of Dover: "We have recently encountered numerous service members who have precipitation and exacerbation of headache syndromes with concomitant receipt of the anthrax vaccine. The immunopathogenic mechanism has yet to be established."

Tam suffers from severe migraine headaches and has been placed on 100 percent military disability.

Some civilian experts say squalene suppresses the immune system so that people predisposed to specific illnesses can get sick years earlier than normal. Some young troops have reported illnesses usually seen by people in their 60s and 70s.

One Dover pilot, who received at least one injection with squalene, said he is able to function only by taking painkillers every day.

"Without my meds, I can't shower or feed myself. I'm non-functional," he said. "Without my meds, I curl up into a fetal ball."

*Evidence of squalene*

The FDA gave limited approval for the Defense Department to test vaccines boosted with squalene during the 1990s. The results of those tests are confidential. But the FDA has not given final approval for human use in the United States.

Asa voiced concerns about the possibility of squalene in anthrax vaccine as early as 1994. In August 1997, retired Vice Adm. Harold M. Koenig, then surgeon general of the Navy, said his office began receiving inquiries about the danger of the anthrax vaccine.

"I sent a request to the Army to ask for information, and they said there had been squalene in trace amounts in vaccines for a long, long time," Koenig said.

That same year, Asa and Tulane University researchers Yan Cao and Garry tested the blood of 56 patients, most suffering with symptoms, and found that most of the samples had antibodies - proteins produced by the immune system to fight harmful foreign substances - to squalene. Their research, published in February 2000 in the journal Experimental and Molecular Pathology, concluded that even trace amounts of squalene could cause autoimmune disorders.

*Dover is ground zero*

In April 1999, as word of Asa's work spread, Grieder asked the Pentagon to brief him and his pilots. The Air Force sent a lieutenant colonel to Dover, but the briefing wasn't well received.

"The guy made just ridiculous comments," Grieder said.

Retired Lt. Col. Jay Lacklen, one of Grieder's former pilots who attended the briefing, said, "At one point, responding to a question about the vaccine, this lieutenant colonel from the Pentagon told all of us, 'I don't know and I don't care.' "

Midway through the briefing, Grieder stood up, interrupted the Pentagon staffer and announced that he had decided to halt the anthrax vaccination program for all personnel under his command.

Grieder called his boss at the Pentagon to tell him what he had done. Grieder was called to Washington the next day to discuss his actions before a group of generals.

After hearing him out, the Air Force assembled a blue-ribbon panel of briefers, headed by Lt. Gen. Charles Roadman, then the surgeon general of the Air Force.

In May 1999, Roadman brought a team of civilian and military medical experts to Dover, including experts from the Army's Medical Research Institute of Infectious Diseases, the military's bio-weapons research center at Fort Detrick, Md.

Roadman began his briefing encouraging those packed into the room to trust the Air Force.

He then turned to the issue of squalene, the real reason for the packed room.

"Let me say this as succinctly as I can: There is not, there never has been squalene as an adjuvant in the anthrax immunization - period," said Roadman. He said two of the five batches sent to Dover had been tested and no squalene was detected.

Ten months after the briefing, the Army applied for a patent for a new way to make anthrax vaccine with squalene as an ingredient. The patent was granted two years later.

Smith, the UD microbiologist, reviewed the patent application for The News Journal and noted that squalene was a component. The purpose of the squalene was not explained in the patent.

"I guess I would be curious why they put squalene in there," Smith said.

The Army has refused to discuss the patent.

*Vaccinations resume*

After that presentation, Grieder allowed the anthrax vaccinations at the base to resume. Two months later he was transferred to an administrative job in Washington.

After Grieder's decision to allow the vaccinations to resume, 55 of the 120 pilots assigned to the reserve air wing at Dover quit rather than submit to the shots.

In October 2000, the FDA announced it had found squalene in all five batches of vaccine sent to Dover - the lots Roadman said were safe.

Grieder, who was already in a new job at the Pentagon and realizing that his Air Force career was over, said he knew then that he and his troops had been deceived. After retiring the following year, he has devoted himself to finding out why.

Defense officials deny that personnel at Dover were subjected to illegal experiments.

"That's just wrong," said Roadman, who is now retired. "Unfortunately, you can have a disagreement where neither party is lying."

When pressed about Grieder's allegations, official spokespersons up and down the chain of command referred questions to others, refused to comment or issued blanket denials.

Maj. Cheryl Law, the public affairs chief at Dover Air Force Base, referred questions to the Defense Department. Law also sent an e-mail to every first-sergeant, group commander, squadron commander, public affairs officer and division chief on the base, warning them not to talk with a News Journal reporter.

Lt. Col. Frank Smolinsky, public affairs chief for the secretary of the Air Force, said the vaccine was safe and that he did not know whether experiments on troops took place. He referred further questions to the Air Force surgeon general.

Bettyann Mauger, the public affairs chief for the surgeon general, said no experiments occurred in Dover. She referred reporters to the Defense Department and the government's anthrax vaccination Web site.

Jim Turner, a civilian public affairs officer at the Defense Department, declined to comment. He also referred reporters to the government's anthrax vaccination Web site.

Col. John Grabenstein, deputy director of the Military Vaccine Agency, said of Grieder's allegations: "It is completely false. There were no medical experiments involving anthrax at Dover or anywhere else."

*Contamination blamed*

Aside from denying that an illegal experiment took place, military officials focus mainly on explanations of how squalene got into the vaccine shipped to Dover. Several blamed a dirty fingerprint they said somehow came in contact with the vaccine.

"The supposition is, squalene in the oil from a fingerprint was added through contaminated lab work," Grabenstein said. "I think that's the most logical explanation."

Dr. Tom Waytes, chief medical officer for the company that made the vaccine, said the minute levels of squalene found do not suggest that it was added to boost the effect of the vaccine.

"I believe it's more likely caused by contamination," said Waytes, who works for Michigan-based BioPort.

BioPort is the only firm that manufactures the anthrax vaccine for the U.S. government.

Waytes blamed the FDA for adding squalene to the vaccine during its testing process.

"BioPort never put squalene in the anthrax vaccine, and I'm not convinced there ever was squalene in the vaccine," Waytes said. "It's most likely caused by the testing process."

Several batches of vaccine produced by BioPort were first tested by Stanford Research Institute, a private firm not affiliated with Stanford University.

This testing did not detect squalene, but FDA tests did.

"The FDA came back using more sensitive tests, and found very minute amounts in the five different lots," Waytes said. "The fact that it could have been due to contamination has never been ruled out."

Lenore Gelb, a Washington D.C.-based spokeswoman for the FDA, declined to comment on BioPort's allegations. She referred reporters to the government's anthrax vaccination Web site, which blames the vaccine contamination on a fingerprint.

"The FDA notes that these minute quantities could have come from processing during FDA tests [squalene is present in the oil in fingerprints]," the Web site states.

Experts, including several civilian immunologists, scoffed at the fingerprint theory.

Roadman, the former Air Force surgeon general, has said any squalene detected occurred naturally.

"As you know I haven't tried to explain this, but squalene is a naturally occurring chemical compound," Roadman said.

Roadman could not say how the squalene ended up in the vaccine sent to Dover.

"I can't tell you that," he said. "I don't know."

In fact, the military never launched an investigation of how squalene got into the vaccine.

Lacklen, a retired senior pilot who received the full program of anthrax inoculations in Dover, has spearheaded a drive to rebut the military's versions of events. He harbors no doubt that senior military officers experimented on him, his fellow pilots and his crews.

"They have squandered generations of trust and goodwill for a program that violated U.S. law and the Geneva conventions," Lacklen said. "They have jeopardized America's front-line troops, and therefore, the safety of the nation."

*Health effects disputed*

Regardless of how squalene may have gotten into the vaccine, military officials deny that it occurs in amounts that could cause harm.

The research of Asa, Cao and Garry - published four years ago, suggesting that even trace amounts of squalene could cause harm to humans - led Congress and other researchers to call for further study.

In a September 2000 letter to former U.S. Rep. Jack Metcalf, a Republican from Washington state who led a one-man investigation into the anthrax vaccination program, an immunologist said squalene should be studied as a possible factor in serious illnesses.

"The real question is whether squalene in parts per billion was added to the vaccine preparations given to the military, as well as whether this concentration of squalene could alter the immune response," wrote Dr. Dorothy Lewis, associate professor of immunology at the Baylor College of Medicine in Houston, Texas. "More research needs to be done to answer these questions, but it is possible that very small amounts of a biologically active product could induce an immune response, either to the molecule itself or it could boost immune responses to other agents in the mixture."

Lewis declined to comment about her letter.

Numerous studies on the effect of squalene on laboratory rodents suggest that the substance suppresses the immune system. The Defense Department has refused to release the results of human tests of vaccines boosted by squalene conducted in the 1990s.

Despite the official denials, some military physicians have concluded that the Dover vaccine harmed some servicemen and servicewomen.

The medical records of a Dover pilot, who feared for his career if his name was used in this story, show that several military physicians linked his advanced arthritis to the vaccine.

"The symptoms began after anthrax immunization, and are in line of duty," the records say. The pilot's records also reveal the presence of an antigen associated with autoimmune disorders.

Several members of the military brought their concerns to Congress in July 1999, during testimony before the House Committee on Government Reform's Subcommittee on National Security, Veterans Affairs and International Relations.

Capt. Michelle Piel was a C-5 Galaxy pilot stationed at Dover.

"All my life I've wanted to fly and serve my country to the best of my ability," she told the subcommittee.

Piel became ill after her first two injections with the vaccine. Her arm grew numb, the right side of her head filled with fluid, and she was grounded because of dizziness.

She testified the dizziness progressed to the point where she was unable to drive, read or concentrate. She was so tired she slept most of the day, and was unable to keep food down.

A total of 12 military and civilian physicians were unable to diagnose her illness. Months later, when a lump was removed from her breast, her symptoms worsened.

"There is no way that I know of to prove that the anthrax vaccine caused any of this," she told the subcommittee. "All I can say is that I became uncharacteristically ill after I started taking the anthrax shots."

Lt. Richard Rovet worked at Dover's Flight Medicine Clinic, where his duties included nursing, case management and patient advocacy.

Rovet described to the subcommittee the adverse reactions to the vaccine he had seen in patients at the clinic.

"We have been told time after time that the vaccine is entirely safe, yet there is a disparity between what we are told and what we are seeing," Rovet said.

The military's anthrax Web site claims the vaccine is safe, because "The Food and Drug Administration individually approves each lot before release."

But FDA documents obtained under the Freedom of Information Act show that the FDA no longer tests the lots for squalene.

Grabenstein said testing for squalene is not necessary.

"We have looked at 30 some lots, and found it at levels below the level in the human bloodstream," he said. (A lot includes 1.8 million doses of vaccine.) "It would achieve nothing in science to go looking for this chemical already in your bloodstream."

*Calls for change ignored*

That opinion was not shared by Rep. Metcalf, who conducted a three-year investigation into the anthrax vaccine.

Metcalf's investigation revealed "that squalene, a substance in unapproved adjuvant formulations, was found in the anthrax vaccine in amounts that could boost immune response - raising the possibility that squalene was used in inoculations given to Gulf War-era vets. GAO science investigators have documented concerns regarding the use of novel adjuvant formulations in vaccines, including squalene."

Metcalf, who is in ill health, was unable to comment.

Sens. Joe Biden and Tom Carper and Rep. Mike Castle, all of Delaware, would not comment about Col. Grieder's allegations. Through their respective spokespersons, they said they didn't know enough about Grieder's claims.

The GAO investigators reported a reluctance by the Defense Department to admit it had conducted five clinical trials with squalene, and had plans for one more.

"In fact, in most cases they only admitted to conducting research after we had discovered it in public records," Metcalf's report states. "On three occasions people attending the conference did not report their own research with squalene adjuvants."

Metcalf and the GAO found that the Defense Department experimented with adjuvants "to use fewer inoculations, get a better response and to check unconquered antigens."

In March 1999, the GAO presented its report and called on the Defense Department to conduct research that would reveal whether Gulf War veterans had squalene in their blood.

The department accused the GAO of being "scientifically and fiscally irresponsible."

Six months later, Metcalf sent a letter to then-Secretary of Defense William Cohen, calling on him to comply with the GAO recommendations. Metcalf also called on the Defense Department to track down the source of squalene in the vaccine.

The Defense Department never complied.

*No legal option*

The Uniform Code of Military Justice specifies that military personnel have no right to refuse a lawful order. Military judges have ruled that the order requiring service members to take the anthrax vaccine is lawful.

Phil Cave, a Virginia-based defense attorney, has represented three service members who have refused to take the anthrax vaccine.

"The issue of whether the Defense Department can do this is pretty well resolved by the courts," Cave said. "I have to tell them the law considers it a lawful order. If they refuse, they risk prosecution, discharge and jail."

Cave was successful at lessening the punishment in his three cases. Two received minor admonishments. One lost rank and pay.

Other personnel haven't been as lucky. Several anthrax refusers have received dishonorable discharges coupled with several months of confinement.

Many of the military personnel interviewed for this story said they were forced to choose between their health and their career. Cave said the likelihood of military punishment is significant for those who refuse vaccination. "I have to advise them it's in their best interests to take it."